Status:
RECRUITING
Cerebellar Deep Brain Stimulation for Movement Disorders in Cerebral Palsy in Children and Young Adults
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Dyskinetic Cerebral Palsy
Dystonic Cerebral Palsy
Eligibility:
All Genders
7-25 years
Phase:
NA
Brief Summary
The purpose of this study is to test the safety of placing Deep Brain Stimulators (DBS) in a part of the brain called the cerebellum and using electrical stimulation of that part of the brain to treat...
Eligibility Criteria
Inclusion
- Diagnosis of DCP (dystonic and/or choreoathetotic cerebral palsy) with or without comorbid spasticity, with a clear history of hypoxic ischemic brain injury preceding motor symptoms made by a pediatric neurologist, with supporting MRI findings.
- Age 7-25 at the time of surgery.
- Gross Motor Function Classification System (GMFCS) Levels II-V.
- History of appropriate therapy with oral medications with inadequate relief as determined by a movement disorders or pediatric neurologist. Prior history of selective dorsal rhizotomy is allowed.
- Patient and family have requested surgical intervention with DBS for their movement disorder.
- No gross cerebellar abnormalities observed and reported on structural MRI.
- Written informed consent and written/verbal assent for those younger than 18 years of age.
- Ability to comply with study follow-up visits for brain recordings, neuroimaging and testing of sham and effective stimulation and clinical assessments.
Exclusion
- Coagulopathy, uncontrolled epilepsy, severe cardiopulmonary or gastrointestinal conditions, or other medical conditions considered to place the patient at elevated risk for surgical complications.
- Pregnancy: all women of child-bearing potential will be required to have a negative urine pregnancy test prior to undergoing their surgical procedure.
- Exclusion of genetic mimics of cerebral palsy: exclusion of conditions that manifest with a clinical syndrome similar to CP, in the absence of documented risk factors or neuroimaging findings consistent with a history of brain injury or congenital cerebral malformation. Work up may include comparative genomic hybridization (CGH) microarray and multi-gene panel and/or whole genome or whole exome sequencing.)
- Severe fixed contractions and skeletal deformities that would preclude determination of improvement.
- Traumatic brain injury (i.e., non-accidental trauma) or history of infectious or autoimmune encephalitis.
- Requirement of diathermy, electroconvulsive therapy or transcranial magnetic stimulation.
Key Trial Info
Start Date :
March 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2029
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06122675
Start Date
March 26 2024
End Date
March 31 2029
Last Update
March 27 2025
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94158